Modular staged reality simulator

ABSTRACT

This invention is directed to a modular staged simulator and a process of simulating medical trauma and maladies for the purpose of training or certifying individuals including medical professionals. More specifically, this disclosure relates to ex vivo training exercises as opposed to traditional forms of training using intact cadavers, in vivo surgery on animal subjects; and supervised apprenticeship performing surgery on human subjects with trauma or maladies under the watch of a skilled medical practitioner.

RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 61/408,413, filed Oct. 29, 2010 entitled “Modular StagedReality Simulator” naming Richard H. Feins et al. as inventors. Theentire contents of which are hereby incorporated by reference includingall text, tables, and drawings.

FIELD OF THE INVENTION

This disclosure relates generally to the process of simulating medicaltrauma and maladies for the purpose of training or certifying medicalprofessionals. More specifically, this disclosure relates to ex vivotraining exercises as opposed to traditional forms of training usingintact cadavers, in vivo surgery on animal subjects; and supervisedapprenticeship performing surgery on human subjects with trauma ormaladies under the watch of a skilled medical practitioner.

BACKGROUND

Context.

Historically, surgical training involved an apprenticeship modelprovided almost exclusively in a hospital setting. Residents performedsurgery under the supervision of more experienced surgeons. The type ofsituations presented to the surgeon trainee was largely driven by chanceas the nature and timing of situations needing surgery found in patientswas not under anyone's control. This model of using a stream ofsituations as presented by clinical service of human patients does notprovide a model for repetition until mastery. As the number of hoursthat residents are available for surgery has decreased, the range ofsurgical events presented to surgical residents has decreased. Thefailure rate for surgery board certification exams is now in the rangeof 26 percent. For specialized board certification such as thoracicsurgery, the rate has been as high as 33 percent.

Virtual reality training based on the field sometimes called seriousgaming or alternative learning techniques has value for teaching medicalproviders interviewing or diagnostic skills. Virtual reality trainingmay be of use for demonstrating the ability to prioritize in triage andfor showing knowledge of the sequence of steps but does not allowpractice of the specific tactile skills used in surgical processes.

SUMMARY OF THE DISCLOSURE

Aspects of the teachings contained within this disclosure are addressedin the claims submitted with this application upon filing. Rather thanadding redundant restatements of the contents of the claims, theseclaims should be considered incorporated by reference into this summary.

This summary is meant to provide an introduction to the concepts thatare disclosed within the specification without being an exhaustive listof the many teachings and variations upon those teachings that areprovided in the extended discussion within this disclosure. Thus, thecontents of this summary should not be used to limit the scope of theclaims that follow.

Inventive concepts are illustrated in a series of examples, someexamples showing more than one inventive concept. Individual inventiveconcepts can be implemented without implementing all details provided ina particular example. It is not necessary to provide examples of everypossible combination of the inventive concepts provided below as one ofskill in the art will recognize that inventive concepts illustrated invarious examples can be combined together in order to address a specificapplication.

Other systems, methods, features and advantages of the disclosedteachings will be or will become apparent to one with skill in the artupon examination of the following figures and detailed description. Itis intended that all such additional systems, methods, features andadvantages be included within the scope of and be protected by theaccompanying claims.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a top view of a segmented mannequin A-100. The mannequin mayinclude certain permanent features such as a mannequin head A-10,mannequin feet A-20, mannequin hands A-30.

FIG. 2 shows a segmented mannequin A-100 with an open body cavity B-10without the staged reality modules A-40 and A-50.

FIG. 3 shows a diagram for a pulsatile air pump.

FIG. 4 shows a leg trauma mannequin D-10.

DETAILED DESCRIPTION

FIG. 1 is a top view of a segmented mannequin A-100. The mannequin mayinclude certain permanent features such as a mannequin head A-10,mannequin feet A-20, mannequin hands A-30. These permanent features maybe made of a material that roughly approximates the feel and weight of ahuman component although without the need to emulate the properties oftissue when cut or sewn. These components could be obtained from sourcesthat provide mannequin parts for mannequins used for CPR practice. Thepermanent mannequin parts used away from the surgical sites are there toassist in the perception in the staged reality that the patient is aliving person. Alternatively, preserved parts from a cadaver may beused. In other alternatives, these body portions that are not directlyinvolved with a staged reality of an event requiring surgery may beomitted and covered with drapes.

Staged reality component A-40 may be some subset of the mediastinum. Forexample, A-40 may represent a heart and pair of lungs. A separate stagedreality module present in FIG. 1 is a spleen module shown as A-50. Notethat while this example shows two active staged reality modules, in manytraining exercises, a single staged reality module will be presentedwith a number of repetitions.

The remainder of the segmented mannequin A-100 may be filled with aseries of mannequin filler pieces A-60. The filler pieces may be made ofballistic gelatin. Ballistic gelatin approximates the density andviscosity of human muscle tissue and is used in certain tests offirearms and firearm ammunition. Approximating the density of humantissue may add to the realism by adding weight to the mannequin segmentsthat approximates the weight of actual human components so that liftinga leg of the mannequin approximates the effort to lift a human leg.Alternatively, multiple staged reality modules may be present on singlemannequin.

Filler pieces made of ballistic gelatin may have a finite life as thatmaterial degrades. An alternative material for filler pieces may be madefrom commercially available synthetic human tissue from a vendor such asSynDaver™ Labs that supplies synthetic human tissues and body parts.SynDaver™ Labs is located in Tampa, Fla. and has a web presence athttp://www.syndaver.com/. Some mannequin filler pieces may be sized tofill in around a specific staged reality module such as the spleenstaged reality module. Others may be standard filler pieces for thatparticular mannequin. (A child mannequin or a mannequin for a superobese patient may have proportionately sized filler pieces).

FIG. 2 shows segmented mannequin A-100 with an open body cavity B-10without the staged reality modules A-40 and A-50. FIG. 2 also lacks themannequin filler pieces A-60 but retains the permanent mannequin partsA-10, A-20 and A-30.

The mannequin may include drain gutters and drain holes to remove excessliquid from the body cavity (not shown).

FIG. 2 includes a high level representation of the control system.Master-controller B-100 is connected to a series of umbilical cables,shown here in this example as umbilical cords B-20, B-30, B-40, andB-50. The mannequin may have fewer than four umbilical cables or morethan four umbilical cables without departing from the teachings of thepresent disclosure. As described in more detail below, each umbilicalcable may provide some combination of one or more pneumatic supplylines, one or more pressurized fluid supply lines, one or moreinstrument communication buses, and low voltage electrical supply topower module electronics and sensors.

FIG. 2 includes a series of ports P at various points along the fourumbilical cables. The ports P allow for a staged reality module to beconnected to an umbilical cord to receive pressurized fluids, pneumaticair (or other gas), connection to instrument communication buses, andlow voltage electrical supply. While for simplicity, each port P isshown as an enlarged dot, a port is likely to have a series of differentconnections for different services provided to a module. Unless the portis located at the distal end of an umbilical cable, the port may appearas a short branch that is part of a T-connection to the umbilical cable.

A particular module may connect to one or many different connections.Several staged reality modules (such as A-40 and A-50) may be connectedto ports along one umbilical cable (B-40). A designer of a comprehensivemediastinum module representing a number of structures found in thethorax cavity might find it useful to connect to ports on two parallelumbilical cables (such as B-30 and B-40) in order to minimize routing ofconnectors within the module.

FIG. 2 includes a bar code scanner B-60 that may be used to read barcode information from the packaging for the staged reality module. A barcode or other optical code could be used to convey a unique identifierfor the module (source and unique serial number). A series of bar codes,a data matrix code (a two-dimensional matrix bar code), or some otheroptical code could be used on the module packaging to convey an array ofdata about the module. This data could be different for different typesof modules but it may include the creation date of the module, theharvest date when the tissue components of the module were collected,and characterization data that may be relevant.

Characterization data may include:

A) a lot number which would provide a way to know that a given set ofmodules was created at the same time and intended to be used to providesubstantially repeatable staged reality simulations;

B) a grade number which would apply across more than one lot so thatmodules created at different times but to a certain array of standardswould have the grade number so that modules within the same grade numbercould be used if a sufficient number of modules within a particular lotnumber were not available;

C) an indication of the level of blockage of certain vessels;

D) an indication of the level of pliability/stiffness of certain tissuestructures (which may increase the level of difficulty for certainprocedures and mimic characteristics of certain patient populations);

E) an indication of the level of obesity associated with this modulewhich may include the use of simulated fatty material that was added tothe module to obfuscate the structure of the underlying tissue as oftenhappens in actual surgery.

One material found to be suitable is called “goop”. A recipe for goopfound at http://www.makingfriends.com/r_goop.htm is below:

GOOP

Mixture 1: ¼ cup Cornstarch

4 oz. white glue

Mixture 2: ½ tsp. Borax

¼ cup Warm Water

Liquid Food Coloring

Sift cornstarch into bowl. Add glue. Mix well. In second bowl mix water,food coloring and Borax until dissolved. Pour Mixture 2 into Mixture 1.Stir constantly for 2 minutes even after goop forms. Kneading will workout some stickiness.

In general, the organs may be characterized using a wide variety ofavailable metrics. These may include volume of ventricles, stiffness ofthe muscle tissue (restitution test), specific gravity, % fat, pressuretesting, etc. The recorded metrics will be specific to the scenariobeing replicated. Ideally, the organs selected are as close to the sizeand weight of human organs.

The bar code scanner may also be used to read bar codes on equipment orfaux drug delivery devices to augment the simulation with recording thereceipt of the therapy from the equipment or provision of a specificamount of a specific drug (even if no drug is actually delivered to themannequin). This information may be used by the master-controller orcommunicated to one or more staged reality modules to alter the stagedreality. For example, the intramuscular or intravenous delivery of adrug may alter the rate of bleeding, the heart rate, or some otherparameter that impacts the presentation of the staged reality.

Functions of the Master-Controller

Master-controller B-100 is shown in FIG. 2 as a single component but itmay in practice be distributed over several pieces of equipment.

Master-controller provides to the umbilical cables one or more pneumaticsupplies. One pneumatic supply may be a closed loop system where airflow passes into and back from the umbilical cables on a periodic basis.For example, to support a staged reality of a beating heart, onepneumatic supply line may have air that pulses into the pneumatic lineat 78 beats per minute. Optionally, this rate may be adjustable and maybe altered to simulate a heart that stops or goes into some form ofdistress. Inflatable elements within the staged reality modules may thusexpand and contract as paced by the pulses of air. Having a closedsystem avoids situations where staged reality module elements areover-filled. The amount of air provided by the pulse into the pneumaticline may be fine-tuned by the operator in order to adjust thesimulation.

A pulsatile pump which better emulates a heartbeat than a sinusoidaloscillation of air in the pneumatic line may be included in themaster-controller or the master-controller may receive pulsatile airfrom an external pulsatile pump. One suitable pulsatile pump isdescribed in U.S. Pat. No. 7,798,815 to Ramphal et al for aComputer-Controlled Tissue-Based Simulator for Training in CardiacSurgical Techniques (incorporated herein by reference). A pulsatile pumpmay be created as indicated in FIG. 3.

Additional pneumatic supply lines at various target air pressures may beincluded in the umbilical cable.

The umbilical cable may include lines at ambient pressure (vented toambient) or at a slight vacuum to allow expanded balloon-type structuresto be emptied.

The master-controller may provide one or more fluids. The fluids maycontain medical grade ethanol, dyes, and thickening agents. Medicalgrade ethanol has been found useful in maintaining the staged realitymodules and in making the staged reality modules inhospitable toundesired organisms. Ethanol is useful compared to other chemicals whichmay be used to preserve tissue in that the ethanol maintains thepliability of the tissue so that it behaves like live tissue in apatient. A mixture with 40% ethanol works well, but the mixture shouldbe made with an effort to avoid flammability when exposed to sparks or acauterization process. Ethanol is desirable in that it does not producea discernable odor to remind the participant that this is preservedtissue.

The storage life of some staged reality modules may be extended bystoring them with fluid containing ethanol. A particular staged realitymodule that is not expected to be exposed to ignition sources should bemade with an ethanol mixture that would be safe to have in proximity ina mannequin adjacent another staged reality module that did haveignition sources.

The master-controller may isolate the umbilical cable or cables from thefluid supply to allow the replacement of a module to allow the traineeto repeat a simulation with a new staged reality module.

Some staged reality modules may have prepared the module by connectingthe venous and arterial systems together so that one pressurized fluidsupply may animate both the arterial and venous vessels by filling themwith colored fluid. The pressure for the fluid may be maintained by merefluid head as an IV bag is suspended at a desired height above themaster-controller or the master-controller may provide fluid at a givenpressure using conventional components.

The umbilical cable may be provided with two blood simulating fluids,one being dyed to resemble arterial blood and a second dyed to resemblevenous blood.

When the mannequin is to be used outdoors with a low ambienttemperature, the staged reality module may have a circulation path thatallows a warm fluid (approximately body temperature) to be circulatedthrough the staged reality module and the umbilical cable to maintainthe warmth of the tissue in the staged reality module. For stagedreality modules that are expected to be completed within a short periodof time, the staged reality module may be preheated to body temperaturebefore the staged reality event and the fluids provided may be warmed toavoid cooling the staged reality module even when the fluid merely fillsvessels in the staged reality module and is not circulated.

The umbilical cable may be provided with fluid lines for one or morenon-blood fluids to be simulated such as digestive fluids,cerebral-spinal fluids, lymphatic fluids, fluids associated withpulmonary edema, pleural effusions, saliva, urine, or others fluidsdepending on the disease or trauma to be simulated.

The fluid and pneumatic connections used to connect the staged realitymodule to the various supplies on the umbilical cable may be anysuitable connector for the desired pressure. Quick-connect fittings maybe preferred so that the act of replacing a module with a similar moduleto allow the trainee to try it again may be accomplished quickly.

Depending on the quick-connect fitting used, the port may need to haveblanks inserted to close the port to flow. When a module is to beconnected to the port, the blank is removed and the module is connected.

The master-controller may record the volume of fluids and gas providedto the particular lines or alternatively the pressure maintained onparticular lines over time. This data record may be used to assess whena trainee effectively ligated a blood vessel or shut off some otherstructure such as a urinary tract.

The umbilical cable may include one or more instrument control cables.Control cables with common interface standards such as USB (UniversalSerial Bus) may be used. The USB connection may be used to provide powerto instruments and local logic devices in the staged reality modules.One of skill in the art will recognize that other data communicationprotocols may be used including RS-232 serial connection, IEEE 1394(sometimes called FireWire or i.LINK), and even fiber optic cableconnections.

The USB connection allows for communication between a module and themaster-controller. Depending on the staged reality presentation thecommunication may be to the module such as:

A) The master-controller may send random or triggered commands for astaged reality component to twitch within a staged reality module.

B) The master-controller may send a command to one or more stagedreality modules to instigate quivering such as may be seen from apatient in shock. The staged reality module may implement quivering byopening and closing a series of small valves to alternatively connect asmall balloon like structure to a high pressure gas via a port on theumbilical cable or to a vent line in the umbilical cable via theumbilical cable port. The valves providing the pressurized gas orventing of the balloon-like structure may be under the local control oflogic within the staged reality module or they may be controlleddirectly from the master-controller.

C) The experience of staged reality may be increased by having more thanone staged reality module quiver at the same time. Mannequins may makegross motions in response to pain such as sitting up or recoiling to addto the staged reality. This may startle the participant, but that may bea useful addition to the training.

The USB connection allows for communication from the staged realitymodule to the master-controller such as a time-stamp when the moduledetects the surgeon starting to cut into a portion of the module,pressure readings, accelerometer indications (respect for tissue).

The master-controller may receive input from a simulation operator. Thesimulation operator may trigger adverse events that complicate thestaged reality scenario such as a simulated cardiac event. The adverseevent may be added to challenge a participant that has alreadydemonstrated mastery.

The master-controller may serve as part of a data collection system thatcollects data about the training of each particular participant so thatthe effectiveness of one training regime for one population ofparticipants can be compared with the effectiveness of another trainingregime on another population of participants so that the differences ofeffectiveness can be quantified.

The master-controller may have access to the training records for aparticular participant in order to assess the need for additionalrepetitions of a particular training module.

EXAMPLE Severe Trauma to Lower Leg

FIG. 4 shows a leg trauma mannequin D-10. The leg trauma mannequin D-10may be A) full sized as shown here; B) just from the waist down; or C)just the left leg. Leg trauma mannequin D-10 may be connected viaumbilical cable B-30 to master-controller B-100. The leg traumamannequin D-10 includes a cavity D-20 that may receive a leg traumastaged reality module D-30. The staged reality module D-30 may have abone element that may be a bone harvested from a cadaver, a boneharvested from an animal, or a bone element manufactured for use in thestaged reality module. Tissue harvested from an animal may be combinedwith the bone elements to create a staged reality module. This tissuemay be augmented with artificial blood vessels.

Thus one of the teachings of the present disclosure is that it may beadvantageous to create hybrid staged reality modules comprising acombination of human cadaver components combined with harvested animaltissue and possibly augmented with synthetic components.

The staged reality module D-30 may protrude from the mannequin D-10 toallow the participant to apply a tourniquet to stem massive blood flowsuch as from a car accident, battle wound, or land mine injury. Atourniquet applied incorrectly will destroy the tissue more distal tothe heart than the tourniquet. Thus, training on the appropriatetechniques will improve clinical outcomes and quality of life for actualwound victims.

The staged reality module D-30 may be part of a group of staged realitymodules made to a particular standard so that a participant'sperformance in stopping the blood flow may be meaningfully compared toprior performances by this participant against this particular stagedreality or to compare participants against a pool of participants thathave participated in this staged reality (including participants thathave used analogous mannequins at other training facilities). Asdiscussed below, the lot number or set of standards that govern aparticular staged reality module may be communicated to themaster-controller by a bar code reader or other input device.

The staged reality may be quantitatively assessed by gathering thevolume of blood loss and the pressure levels that can be maintained onthe venous and arterial blood lines. Graphs of blood loss and pressurelevels over time may be presented to the participant as part of theinformed assessment review of the participant's performance.

Input from Observer to Master-Controller.

The master-controller may optionally receive real time input from theskilled observer to augment the quantitative measurements being madeduring the staged reality procedure.

Audio Output from the Master-Controller

The master-controller may be used to augment the staged reality byproviding background sounds such as would be found in a hospital duringa particular type of surgery or would be found during abattlefield/first responder scenario.

The master-controller may emit specific sounds such as a patient in painwith groans or other sounds indicating pain. Input from one or morestaged reality modules indicating that the patient is being moved orotherwise likely to be experiencing elevated pain levels may triggermore frequent, loud, or intense expressions of pain.

The master-controller may emit odors that are relevant to enhancing thestaged reality. The odor of burnt flesh, of blood or other body fluids,or simply the smell of smoke from a plane crash or battle activity mayhelp make this staged reality event seem real to the participant.

Examples of Staged Reality Effects Example of Xenogenic OrganPreparation

Porcine organ blocks consisting of the heart with pericardium, lungs,trachea, esophagus, and 8-12 inches of aorta were obtained from a localsupplier. No animals were sacrificed for the purposes of our research asthe organ block was harvested from an animal before butchering theanimal for food products.

Organ preparation began with an incision of the pericardium on the rightposterior side of the heart so that it could be reattached with nonoticeable holes when viewed from the left side. The superior vena cava,inferior vena cava, right pulmonary artery, and right pulmonary veinswere then divided with care taken to leave as much vessel length aspossible. After the right lung was detached fully, the organs werewashed extensively to remove coagulated blood from the heart andvessels. All divided vessels except for the main branch of the rightpulmonary artery and right superior pulmonary vein were then tied offusing O-silk.

Small diameter plastic tubes with Luer-Lok® connectors were then placedinto the divided right pulmonary artery and right superior pulmonaryvein, and fixed using purse-string sutures. To create distention of theaorta, silicone caulking was injected to the level of the ascendingaorta.

After the silicone had cured, the brachiocephalic trunk and left commoncarotid were tied off using 0-silk. Finally, the left main stem bronchuswas occluded by stapling the divided right main stem bronchus as well asthe proximal trachea. The left hilum remained unaltered, and allmodifications to the heart were hidden by the pericardium during theprocedure.

Following preparation, the organs were stored at 4 degrees Celsius in10% ethanol containing ½ teaspoon of red food coloring, where theyremained fresh for at least 1 month.

40% ethanol can preserve the organs for over a year. Several hearts thatwere prepared and stored for 18 months performed as well as freshlyharvested organs.

The porcine organ block can be placed in a lower tray to retain fluidsanalogous to a metal baking tray. For purposes of simulating a human,the porcine heart can be rotated to emulate the position of a humanheart in a torso. For example, the left side of the porcine heart can beplaced into the tray with the left lung placed over an inflatable airbladder.

Inflation and deflation of lungs of a real patient causes the rise andfall of the mediastinum. An appropriate volume of air or some otherfluid may be used to inflate and deflate an appropriately sized andplaced container hidden under the tissue to be animated with movement.For example a respiration rate of 20 breaths per minute can be simulatedby periodically expanding an air bladder such as a whoopee cushion, oran empty one-liter IV bag that is folded in half.

Lightly pressurized water/paint mixture resembling blood can be providedthrough a connection to the umbilical cable port to provide bloodemulating fluid into the divided right pulmonary artery and dividedright superior pulmonary vein to distend and pressurize the venous andarterial systems. Static fluid pressure within the vessels was achievedusing gravity flow from a one-liter IV bag. Pressure is limited to avoidsevere pulmonary edema. Extended perfusion times (1-2 hours) may bemaintained without substantial fluid leakage into the airways bypreparing the porcine organ block to occlude the left mainstem bronchusto inhibit leaking and loss of pressure.

A balloon placed in the heart and connected to a closed system airsource to allow for emulating the beating of a heart (such as at a rateof 78 beats per minute) adds to the sense of realism of the stagedreality event.

Thus this staged reality module could be animated by providing one quickconnect fitting to connect the heart balloon to the air supply toprovide the beating heart effect. A second quick connect fitting to adifferent pneumatic connection in the umbilical cable provides the lungmovement air. A fluid quick connect fitting connected to the joinedblood vessels allows for slightly pressured simulated blood to beprovided from the umbilical cable.

As used in this specification, a quick connect fitting is one that maybe connected to a corresponding fitting without the use of tools. Aquick connect fitting may be used to connect to hydraulic line,pneumatic line, electrical line, or digital communication bus.

The container with the staged reality module may include photographsrepresentative of what would be seen in an actual human undergoing thissurgical procedure in order to support the staged reality.

Thus, this animated staged reality module may be quickly inserted into arelevant portion of a segmented mannequin, connected via an array ofquick connect fittings to corresponding fittings on a convenientumbilical cable port to quickly prepare a mannequin for surgery on thissite. Other staged reality modules may be likewise connected. Pressurelevels (such as the height of an IV bag supplying the master-controller)or pulse volumes (for heart or lung motion) may be adjusted at themaster-controller. The mannequin may then be draped to expose therelevant surgical sites.

Optionally, the packaging carrying the staged reality module (theporcine organ block with modifications and quick connect fittings) mayinclude a bar code, data matrix code, other optical code, or othermachine readable data storage device that is accessed by a bar codereader or other reader device in data communication with themaster-controller. Thus data concerning this specific staged realitymodule may be made available to the master-controller and combined withother information gathered during the surgical simulation and made partof a data record for this training or certification session. Anotheroption would be the use of a passive RFID label.

Development of a Module Lot

A group of animal tissue collections may be made from a series ofanimals before butchering for food so that no animals are sacrificedbeyond what would be butchered for food. By collecting a series oftissue collections by the same facility using the same procedure fromthe same herd of animals (same breed, same age, same food), there willbe extensive similarities among the collected tissue samples. As isunderstood by those of skill in art, some features vary even betweenidentical twins such as the vascular pattern around the exterior of theheart so some features cannot be closely controlled. However, certaindegrees of variability can be decreased by clustering tissue samples bygender of donor animal, nominal weight of donor animal, or some otherproperty of the animal or classification made of the harvested tissuesample.

Examples of classification of the tissue samples may include:

A) Some characterization of the amount of fatty material surrounding thetissue of interest.

B) Some characterization of the pliability/stiffness of the tissue.

C) Some characterization of the properties of the relevant blood vesselssuch as degree of occlusion.

D) One way to characterize an organ is the time it takes for a fluid todrip out from a container and into an organ. As the receiving volume ofthe organ will be relatively uniform (for organs of the same size) thismay characterize the ability of fluids to flow through the structures inthe organ and out.

Standardized Trauma

While having similar tissue for use in creating various staged realitymodules within a lot is helpful, the ability to precisely create traumain ex vivo tissue samples is of even greater importance. Havingharvested tissue samples of a similar size and quality allows the tissuesamples to be placed in a jig so that the trauma may be applied in acontrolled way a precise offset from one or more anatomic markers.Examples of trauma include:

A) A set of uniform metal pieces may be created and implanted a setdepth in a set location to allow for a set of shrapnel wounds to beplaced in a series of tissue samples that will become staged realitymodules within a given lot.

B) A particular volume of silicon or some analogous material may beplaced in the same location in a series of harvested lungs to emulatelung tumors.

C) Trauma may be emulated for chemical burns or other trauma to theouter layers of tissue of a faux patient.

D) In lieu of implanting faux ballistic debris, organs placed in jigscould receive ballistic projectiles from a weapon. In order to verifythat the trauma induced fits within the parameters for this particularset of traumatized organs, the trauma could be examined andcharacterized by ultrasound or some other diagnostic imaging method. Onemay also sprinkle a little gunpowder around the wound just before thesession started and ignite it to create fresh burns and realistic smellsof the battlefield.

Spleen Example

A second example of a staged reality module is a spleen that hasreceived a standardized shrapnel injury (precise and repeatableinsertion of standardized pieces of metal rather than actual pieces ofshrapnel from an explosion). The staged reality module for the injuredspleen could be placed as module A-50 (Figure A). The staged realitymodule would be prepared with quick connect fittings to allow connectionto a port on an umbilical cable to provide a source of faux blood and toprovide a clear liquid to weep from the wound. Optionally, the spleenmay have instrumentation to provide an indication of when the spleen wasfirst by cut the surgeon. This information could be conveyed by the databus.

In order to provide a standardized set of injured spleens for testing orsimply for use in an ordered curriculum, a set of substantiallyidentical spleens harvested from donor animals that will be butcheredfor food may be prepared in the substantially same way.

As noted above, the packaging may convey information about the stagedreality spleen module.

Alternatives and Variations

Uses of Modular Staged Reality Mannequins

The examples given above addressed the training of surgeons, possiblywhile they are residents in training to become surgeons or specializedsurgeons such as cardio-thoracic surgeons. The present disclosure may beextended to other situations that would benefit from the ability toprovide repeated staged reality simulations of a particular trauma ormalady such that the medical practitioner may gain experience anddemonstrate mastery of a particular set of skills or capacity to performa particular procedure. Nothing in this disclosure should be interpretedto limiting the teachings from this disclosure to emulations of ahospital surgery or to procedures normally performed by a surgeon. Theterm “surgery” where used in this disclosure should be read expansively(unless expressly limited to a narrower meaning) to include any medicalprocedure, including those performed on a battlefield or by firstresponders.

Non-limiting examples include:

A) Use of staged reality to present to a medical certification applicanta particular staged reality as part of a certification process.Provision of substantially similar staged reality scenarios may beprovided to a set of medical certification applicants at one facility inorder to provide a uniform certification experience for the set ofapplicants. Optionally, the provision of substantially similar stagedreality scenarios may be staged at a range of testing locations and overa range of dates using similarly prepared tissue modules and collectingsimilar data streams.

B) Use of staged reality to provide baseline training to experiencedsurgeons on the roll-out of a new medical procedure so that the surgeonsmay achieve a baseline level of mastery before attempting a procedure ona human patient with or without the assistance of a representative ofthe medical company that developed the new procedure.

C) Use of staged reality to prepare a surgeon or other medicalprofessional who is a member of the military reserves with thetechniques, equipment, and time pressures that may be relevant fordeployment as a military surgeon.

D) Use of staged reality to provide baseline training to those who willbe doing clinical testing of a new medical procedure to allow fordocumentation that the participants performing clinical testing havebeen uniformly trained. The training of participants in clinicaltraining may be performing clinical tests on human or animal subjects.

E) Use of staged reality to provide baseline training to firstresponders and military medics. After mastery in a laboratory setting,the same staged reality experience may be repeated with a field portableunit so that the trainee may attempt to perform the procedure outside,on the ground, in the elements, with poor lighting, with noise and otheractivity around the trainee.

F) Use of staged reality on a pair of segmented mannequins to alloworgan transplant teams to practice a number of repetitions of harvestingcomponents from the donor-mannequin and moving the harvested componentsto the recipient-mannequin.

G) The mannequin could be prepared with appropriate sensors reflectcertain wounds and then used to teach nurses and staff how to move andcare for an injured person, pre or post-surgery.

Gender-Age-Weight

While the figures provided with this disclosure may be limited to asegmented mannequin that is without any specific gender, nothing in thisdisclosure limits the use of staged reality to gender neutral trainingsimulation. Gender specific anatomy including anatomy of thereproductive systems may be used for staged reality training. Stagedreality may be used in connecting with situations involving a pregnantwoman and with a simulated human fetus.

While the figures provided with this disclosure may be primarilyaddressed to adult or slightly oversized adult mannequins (so as toprovide ample room within the mannequin for the staged reality tissue),the present disclosure can be used with a segmented mannequin that issized for use in emulating disease or trauma for an infant or child. Forexample, segmented mannequins with appropriate staged reality modulesmay be useful in providing repeated opportunities for intubating apediatric patient.

The present disclosure may be used in connection with segmentedmannequins that are designed to emulate a morbidly obese patient or evena super obese patient. Alternatively a segmented mannequin that emulatesa severely underweight patient may be useful for training medicalpersonnel that may be exposed to victims of famine.

Orientation and Completeness of the Mannequin

One of skill in the art will recognize that not all procedures are doneon a patient in a supine position. Some procedures are performed on apatient in a prone position so that the posterior aspect of the body isreadily accessible. Some procedures call for lateral entry. Manysurgical procedures call for specific patient positioning using wedges,bean bags, sand bags, stirrups, and other positioning aids. Theteachings of the present disclosure can be used with mannequins withadequate flexibility to assume specific positions as assumed by patientsfor particular procedures or mannequins created in the appropriateorientation to emulate a positioned patient.

Mannequins for battlefield or first responder training may be positionedor manufactured to be in a contorted position not resembling a standardsurgical position used for patients in a hospital.

While a complete mannequin may be the most convincing for creating astaged reality, a mannequin that emulates a portion of a patient such asa limb, the head, or a portion of the torso may be a cost appropriatesolution. Such a mannequin may be useful for field training as therewould be less to carry out to the field.

Some staged reality modules may be used within a general purposemannequin that accepts a number of different staged reality modules at anumber of different umbilical cable ports. These same staged realitymodules may also be used in more limited mannequins including those withas few as one umbilical cable port. Having a standardized connectioneven if there is only one port is useful in that many differentmannequins can be made in accordance with a standard to make it easy forstaged reality modules to be used across mannequins and to have astandard interaction with master-controller units.

Location of Surgical Site

While the segmented mannequin provided to illustrate concepts in thisdisclosure did not feature staged reality modules in the hands, feet, orhead of the mannequin, the teachings of the present disclosure can beextended to those locations so that orthopedic procedures of theextremities, podiatry, certain maxillofacial surgical procedures, dentalprocedures, and even neurosurgery may be simulated.

Sensors Connected to the Trainee

Optionally, the master-controller may monitor one or more data streamsproviding physiological data about the trainee surgeon. Polygraphinstruments are used to detect the stress levels of a person beinginterviewed about a crime or analogous topic. While there is not a needto detect deception by the surgeon trainee, it may be instructive tocapture one or more parameters such as blood pressure, pulse rate,respiration rate, or skin conductivity to see if errors in surgicalprocedure detected by the master-controller or the skilled observercorrespond to indications of elevated or changing stress levels.

A secondary benefit of the collection of data indicative of stress orstimulation level is that this material may be useful in evaluatingwhether certain peripheral stimulus in the simulation promotes thesuspension of disbelief as there may be a marked change in the datastream for a trainee as the trainee shifts into a belief that this is areal patient on the table. Peripheral stimulus may include sounds thatemulate sounds that might be present in a real surgery or firstresponder scenario. Peripheral stimulus may include movement of fauxstaff members treating a part of the patient's body away from thetrainee's surgical site.

Fluid Management

The surgeon participant may be required to emulate actual surgery withthe placement of fluid drains and the use of suction to remove fluidsfrom the surgical site. The fluid removal would be via traditionalsurgical tools rather than routed through the umbilical cable.

Topography of the Umbilical Cable Routing

One of skill in the art will recognize that instead of a series of twoor more parallel umbilical cables, that an umbilical cable loop could beused with two ends that terminate at the central controller and a seriesof ports along the loop.

Use of Working Gases Other than Air

While the examples given above have referenced air as the gas used inthe pneumatic lines, the present disclosure does not rely on uniqueproperties found in ambient air. The air may be modified as is known inthe art to add lubricants or humidity depending on the needs of thesimulation and the equipment involved. In one embodiment, the air may bereplaced with some other gas such as nitrogen.

Video Feeds

Optionally, the staged reality modules could be provided with embeddedendoscopic bundles that could be routed independently of the umbilicalcable to provide the instructor/evaluator with a view of the surgicalsite that might be difficult to view as an observer not directly alignedwith the line of sight of the surgeon. Alternatively, small cameras withbuilt-in analog to digital conversion could connect with a data port onthe umbilical cable to provide video for use by theinstructor/evaluator. The choice of camera technology used for thisapplication will need to be coordinated with the anticipatedavailability of light at the surgical site but the surgical site (onceopened by the surgeon) is typically well illuminated for the benefit ofthe surgeon.

Alternative Pulsatile Air Pump

FIG. 3 shows a diagram for a pulsatile air pump. The air provided to thepulsatile air supply on the umbilical cable can be generated assymbolized by elements in FIG. 3. A linear input source (potentiallystabilized by a linear bearing) moves a contact element C-20 relative toan anchored Ambu bag C-30. An Ambu bag (also known as a bag valve mask(“BVM”)) is a hand-held device used to provide positive pressureventilation to a patient that is breathing inadequately or not at all.The Ambu bag has a number of one way valves useful for this purpose.

One of skill in the art will recognize that moving the contact elementC-20 relative to the Ambu bag will mean that for a portion of the strokeof the linear actuator C-10 that the contact element does not impact theAmbu bag. Thus the input to the Ambu bag C-30 can be altered from asinusoidal input to more of a pulsatile input. Adjustments to the sizeof the Ambu Bag or its analogous replacement, the size of the contactelement C-20 and the stroke length of the linear actuator after contactwith the Ambu Bag will alter the air output at C-40. While the linearactuator C-10 could be a stepper-motor, other simpler solutions such asa windshield wiper motor could be used.

If this air source is used to animate a heartbeat then it would need tooperate at a reasonable pulse rate for example 78 beats per minute. Thispulse rate could be adjustable if desired or relevant to the stagedreality.

Alternatively, if the air source is used to animate movements inresponse to respiration, then the pulses per minute would need to bereasonable for a patient undergoing surgery.

Fine tuning to control the amount of air C-50 provided to the umbilicalcable (not shown) or a series of two or more umbilical cables via aheader (not shown), may be achieved by a ball valve C-60 connected viaTee joint C-70. The ball valve C-60 may be used to divert air to bladderC-80 (such as a pair of balloons one within the other). The bladdershould be operated in an elastic range so that the expanded bladderpresses the air back towards the Ambu Bag when the Ambu Bag is not beingcompressed by the contact element C-20. The bladder may be connected tothe air line by a segmented air nipple.

It may be desirable to maintain the pulsatile air system as a closedsystem so that one or more animation bladders connected to the ports ofthe one or more umbilical cables operate to force back the air into thetubing through operation of the bladder in an elastic range and theweight of the animated tissue.

One of skill in the art will recognize that some of the alternativeimplementations set forth above are not universally mutually exclusiveand that in some cases additional implementations can be created thatemploy aspects of two or more of the variations described above.Likewise, the present disclosure is not limited to the specific examplesor particular embodiments provided to promote understanding of thevarious teachings of the present disclosure. Moreover, the scope of theclaims which follow covers the range of variations, modifications, andsubstitutes for the components described herein as would be known tothose of skill in the art.

The legal limitations of the scope of the claimed invention are setforth in the claims that follow and extend to cover their legalequivalents.

The invention claimed is:
 1. A method of providing a staged reality of afaux patient undergoing surgery comprising: providing at least anemulated section of a patient body with at least one umbilical cablewith at least two connection ports; providing at least one stagedreality module emulating a particular portion of a patient's bodycomprising: a section of animal tissue; at least one quick connectfitting operatively connected to the staged reality module to receive ananimating force to the staged reality module; connecting the at leastone quick connect fitting from the at least one staged reality module toat least one corresponding fitting on at least one of the connectionports; providing a participant an opportunity to provide simulatedmedical services to the faux patient while providing at least oneanimating force to the staged reality module; and removing the at leastone staged reality module and connecting a second staged reality moduleto the at least one umbilical cable to allow the participant anopportunity to repeat the provision of the simulated medical service tothe same emulated portion of the faux patient while using the secondstaged reality module wherein the umbilical cable contains at least onesource for a colored fluid to emulate blood; and at least one pneumaticline connected to a closed system to allow a connected module componentto inflate and deflate to emulate a living patient wherein the emulatedsection of a patient's body uses a mannequin with a cavity containing atleast one umbilical cable, at least one staged reality module connectedto the at least one umbilical cable and at least one filler piecefilling a portion of the mannequin cavity that does not have stagedreality module present for use in the current staged reality of a fauxpatient undergoing surgery.
 2. The method of claim 1 wherein the atleast one filler piece is comprised of synthetic human tissue.
 3. Themethod of claim 1, wherein the at least one staged reality moduleemulating a particular portion of a patient's body is shipped withpackaging that includes information readable by a scanner associatedwith a master-controller used in connection with the one or moreumbilical cables and the scanner reads information about the propertiesof the staged reality module.
 4. The method of claim 1 wherein the atleast one staged reality module emulating a particular portion of apatient's body and the second staged reality module are both createdusing animal tissue and have both been modified to provide substantiallysimilar defects for treatment by the participant so that the participantcan effectively repeat the surgery by having two staged reality modulesthat present the same surgical challenges.